Clinical Trials /

A Study of Atezolizumab as First-line Monotherapy for Advanced or Metastatic Non-Small Cell Lung Cancer

NCT02848651

Description:

This was a Phase II, open-label, prospective, multicenter study designed to evaluate the efficacy and safety of single-agent atezolizumab as a first-line therapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC). In addition, the primary biomarker objective was to measure blood tumor mutational burden (bTMB) and evaluate whether it can predict for improved clinical outcome with atezolizumab.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Atezolizumab as First-line Monotherapy for Advanced or Metastatic Non-Small Cell Lung Cancer
  • Official Title: A Phase II Single-Arm Study of Atezolizumab Monotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer: Clinical Evaluation of Novel Blood-Based Diagnostics

Clinical Trial IDs

  • ORG STUDY ID: ML39237
  • NCT ID: NCT02848651

Conditions

  • Non-Small Cell Lung Cancer

Interventions

DrugSynonymsArms
AtezolizumabMPDL3280A; RO5541267; TecentriqAtezolizumab

Purpose

This was a Phase II, open-label, prospective, multicenter study designed to evaluate the efficacy and safety of single-agent atezolizumab as a first-line therapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC). In addition, the primary biomarker objective was to measure blood tumor mutational burden (bTMB) and evaluate whether it can predict for improved clinical outcome with atezolizumab.

Trial Arms

NameTypeDescriptionInterventions
AtezolizumabExperimentalParticipants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).
  • Atezolizumab

Eligibility Criteria

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Histologically or cytologically confirmed Stage IIIB-IVB NSCLC

          -  For participants who have received prior neo-adjuvant/adjuvant chemotherapy or
             chemoradiotherapy with curative intent for non-metastatic disease: a treatment-free
             interval of at least 6 months prior to enrollment

          -  Participants with any programmed death-ligand 1 (PD-L1) test result by
             immunohistochemistry (IHC) are eligible for the study

          -  Participants without a PD-L1 test result are eligible for the study

          -  Measurable disease per RECIST v1.1

          -  Adequate hematologic and end-organ function

          -  Agreement to remain abstinent (refrain from heterosexual intercourse) or use
             contraceptive methods among women of childbearing potential

        Exclusion Criteria:

          -  Prior treatment with immunotherapy for any stage NSCLC, including early-stage
             (neoadjuvant or adjuvant) disease

          -  Participants with epidermal growth factor receptor (EGFR) sensitizing mutations and
             anaplastic lymphoma kinase (ALK) rearrangements

          -  Active central nervous system (CNS) metastases requiring treatment

          -  Spinal cord compression not definitively treated or not clinically stable

          -  Leptomeningeal disease

          -  Uncontrolled tumor-related pain

          -  Uncontrolled pleural, pericardial effusions, or ascites requiring recurrent drainage
             procedures

          -  Uncontrolled or symptomatic hypercalcemia

          -  Malignancies other than NSCLC within 5 years prior to enrollment, except for those
             curatively treated with negligible risk of metastasis or death

          -  Pregnant or lactating women

          -  History of autoimmune disease, significant pulmonary disease, or significant
             cardiovascular disease

          -  Positive human immunodeficiency virus (HIV) or hepatitis B or C

          -  Active tuberculosis

          -  Severe infection or major surgery within 4 weeks, or oral or IV antibiotics treatment
             within 2 weeks prior to enrollment

          -  Prior treatment with or hypersensitivity to study drug or related compounds

          -  Prior allogeneic bone marrow or solid organ transplant

          -  Administration of a live, attenuated vaccine within 4 weeks prior to enrollment

          -  Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the
             drug (whichever is longer) prior to enrollment

          -  Treatment with systemic corticosteroids or other systemic immunosuppressive
             medications within 2 weeks prior to enrollment
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Percentage of Participants With Objective Response Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Determined by Investigator
Time Frame:Baseline up to 32 months
Safety Issue:
Description:Investigator-assessed objective response rate was defined as the proportion of participants who had a confirmed best overall response of either PR or CR per RECIST v1.1.

Secondary Outcome Measures

Measure:Progression-Free Survival (PFS) Per RECIST v1.1 as Determined by Investigator
Time Frame:Baseline up to 32 months
Safety Issue:
Description:Investigator-assessed PFS by RECIST v1.1 was defined as the time from the first dose of study drug to the time of PD or death from any cause during the study, whichever occurred first.
Measure:Duration of Response (DOR) Per RECIST v1.1 as Determined by Investigator
Time Frame:Baseline up to 32 months
Safety Issue:
Description:Investigator-assessed DOR by RECIST v1.1 was defined as the time from initial occurrence of documented CR or PR until documented disease progression as determined by the investigator, or death, whichever occurred first.
Measure:Disease Control Rate (DCR) Per RECIST v1.1 as Determined by Investigator
Time Frame:Baseline up to 32 months
Safety Issue:
Description:Confirmed disease control rate (cDCR) was defined as the rate of patients with CR or PR as the best response, or SD maintained for 24 weeks, per RECIST v1.1.
Measure:Overall Survival (OS)
Time Frame:From baseline until death (up to 32 months)
Safety Issue:
Description:OS was defined as the time from the first dose of study drug to the time of death from any cause during the study.
Measure:Percentage of Participants With Adverse Events
Time Frame:Baseline up to 32 months
Safety Issue:
Description:Adverse events were defined as any untoward medical occurrence in a subject administered atezolizumab, regardless of causal attribution.
Measure:Percentage of Participants Who Are Alive and Progression-Free (Per RECIST v1.1) at 6, 9, 12, and 18 Months by Various bTMB Quantiles
Time Frame:Months 6, 9, 12, and 18
Safety Issue:
Description:A summary of the number of patients at risk and survival rate for the time points of 6, 9, 12, and 18 months.
Measure:OS by Various bTMB Cutoff Points 16 and 20
Time Frame:From baseline until death (up to 32 months)
Safety Issue:
Description:OS was defined as the time from the first dose of study drug to the time of death from any cause during the study.
Measure:Percentage of Participants With Objective Response (Per RECIST v1.1) by Various bTMB Quantiles
Time Frame:Baseline up to 32 months
Safety Issue:
Description:Objective response rate was defined as the proportion of participants who had a confirmed best overall response of either PR or CR per RECIST v1.1.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Genentech, Inc.

Last Updated

April 28, 2020